(Press release, Cleveland BioLabs, OCT 23, 2013, View Source [SID:1234503972])

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On October 23, 2013 Australian drug development and pharmaceutical company Imugene (ASX:IMU) was pleased to advise that, consistent with its strategy to diversify through acquisition, it has executed a Sale and Purchase Agreement to acquire 100% of Biolife Science Qld Limited (Biolife), a company incorporated in Australia (Press release, Imugene, OCT 23, 2013, View Source [SID:1234509845]).

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Biolife has the rights to a novel cancer immunotherapy platform that has been developed by scientists at the University Medical School in Austria. The scientists have developed a peptide-based immunotherapy that induces a polyclonal antibody response against HER-2/neu associated tumours, including breast cancer and gastric cancer ("HER-Vaxx").

HER-2/neu is a known and validated receptor that is over-expressed on various cancerous tumours, including gastric, breast, ovarian and pancreatic cancers. Having already successfully completed a Phase I human study in breast cancer, a Phase II study in gastric cancer is planned to potentially commence in calendar 2015, subject to FDA approval.

Forrest Capital coordinated the acquisition and will be lead manager for the capital raise.

Key information on the Biolife technology, intellectual property, market potential and previous studies are included in a presentation and Q&A placed on the ASX website at:
View Source

Imugene will, subject to Shareholder approval:

Issue 300 million shares to purchase 100% of Biolife Science Qld Ltd.
Raise an additional A$2.5 million via the placement of 250 million shares at $0.01. The placement will be managed by Forrest Capital, 85 million shares issued within current capacity with the balance subject to shareholder approval.
Dr Axel Hoos current vice president, Oncology R&D at GlaxoSmithKline is expected to join the board as Non-Executive Director.

(Filing, 10-Q, Epizyme, OCT 23, 2013, View Source [SID:1234503840])

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On October 21, 2013 OXiGENE reported the presentation of data from a preclinical study of ZYBRESTAT (fosbretabulin tromethamine/combretastatin A-4 phosphate or CA4P) demonstrating statistically significant differences between the treatment arm and the control arm in a model of pancreatic neuroendocrine tumors (PNETs). The data were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Boston, MA, in a poster session on October 20, 2013 (Press release OXiGENE, OCT 21, 2013, View Source [SID:1234500303]).

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The poster, titled "Combretastatin A-4 Phosphate (CA4P) is effective for the treatment of functional pancreatic neuroendocrine tumors (PNETs) in a transgenic mouse model," was presented by ZiQiang Yuan, MD, Research Assistant Professor, Department of Surgery, Albert Einstein College of Medicine. Steven K. Libutti, MD, FACS, Professor of Surgery and Genetics, Albert Einstein College of Medicine, and Montefiore Medical Center, is the senior author.

This preclinical study was designed to evaluate the efficacy of systemic administration of ZYBRESTAT or CA4P for the treatment of functional insulinomas in a transgenic mouse model of PNETs. PNETs are highly vascularized tumors which originate in the pancreas. Functional PNETs make hormones that can cause a cascade of disease symptoms, resulting in significant morbidity for the patient. An insulinoma is a PNET that causes the over-secretion of the hormone insulin.

The treatment group received ZYBRESTAT three times per week for four weeks, and the control group received a placebo. After four weeks, tumor size, serum insulin levels and other efficacy parameters, including apoptosis (cell death), cell proliferation and effects on tumor vasculature, were assessed. Key results were as follows.

Treatment with ZYBRESTAT resulted in a significant and sustained decrease in circulating insulin, with maximum effect seen by day 17 (p < 0.0001).
The reduction in insulin was accompanied by a significantly reduced tumor size in the treated group compared to the placebo group (p=0.0128).
Treatment with ZYBRESTAT was shown to disrupt tumor vasculature, induce apoptosis (cell death) and inhibit tumor cell proliferation.
ZYBRESTAT was shown to be well tolerated, with no obvious toxicity.

On October 18, 2013 Ablynx reported that it has granted an exclusive,royalty-bearing license to Eddingpharm, a leading Chinese specialtypharmaceutical company, to develop and commercialise its anti-RANKL Nanobody, ALX-0141,in the mainland of the People’s Republic of China, the Hong Kong and MacaoSpecial Administrative Regions, and Taiwan, for all indications, includingosteoporosis and bone metastases (Press release, Eddingpharm, OCT 18, 2013, View Source [SID:1234513851]).

Under the terms of the agreement, Eddingpharm will be responsiblefor the clinical development, registration and commercialisation in GreaterChina of anti-RANKL Nanobody therapeutics. Ablynx will have access to the datagenerated by Eddingpharm to support potential licensing discussions in othergeographic regions.

Ablynx will receive a EUR2 million upfront payment fromEddingpharm and is entitled to receive commercial milestone payments plustiered, double-digit royalties of up to 20%, based on annual net sales ofALX-0141 generated by Eddingpharm in Greater China.

ALX-0141 is a bivalent bi-specific therapeutic molecule composedof two Nanobodies targeting the Receptor Activator of Nuclear factor Kappa-BLigand (RANKL). This bivalent anti-RANKL construct is linked to a Nanobody thatbinds to human serum albumin, extending the drug’s in vivo half-life, and whichmay in turn lead to preferential targeting of diseased tissue. A Phase I studyin healthy post-menopausal women showed that a single administration ofALX-0141 has a strong and very long lasting inhibitory effect on boneresorption biomarkers and was well tolerated with no serious adverse events ordose-limiting toxicity being observed.

Dr Edwin Moses, Chairman and CEO of Ablynx added:
"Eddingpharm is well-positioned to further develop andcommercialise ALX-0141 in Greater China, which represents a rapidly growingarea for bone related disorders. Our Nanobody has strong potential in thismarket, with very good efficacy, as measured by biomarkers, and a clean safetyprofile, and we look forward to collaborating with Eddingpharm and supportingthem to move the programme further in development and beyond."

Mr Ni Xin, Founder, Chairman and CEO of Eddingpharm commented:
"We are very pleased that Ablynx has entrusted Eddingpharmto develop and commercialise its anti-RANKL Nanobody in Greater China. Togetherwith Ablynx, we are committed to bringing this innovative medicine to millionsof patients in the region. This partnership represents a key milestone towardsour goal of establishing Eddingpharm as the partner of choice in China forbiotechnology companies around the world."

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